(454 days)
No
The description focuses on traditional CAD/CAM design and manufacturing processes for dental abutments, with no mention of AI or ML.
No.
A therapeutic device intends to treat or cure a disease or condition. This device is a dental abutment used for prosthetic rehabilitation, which replaces a missing part, rather than treating a disease.
No
The device is a dental abutment intended for prosthetic rehabilitation, not for diagnosing medical conditions.
No
The device description explicitly states the device is made of Ti-6A1-4V ELI (ASTM F136) and is a physical dental abutment. The summary also details non-clinical testing related to the physical properties of the material and device (sterilization, biocompatibility, fatigue testing, MRI review). While a CAD/CAM system is mentioned for design, the final product is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in prosthetic rehabilitation" by being used with a dental implant. This is a direct therapeutic/restorative purpose within the patient's body.
- Device Description: The device is a physical dental abutment made of titanium, designed to be implanted and support a crown or bridge.
- Lack of Diagnostic Function: There is no mention of this device being used to examine specimens (like blood, tissue, etc.) outside the body to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is used within the "bone of the upper or lower jaw arches," which is an in-vivo application.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This dental abutment is a medical device used within the human body for a restorative purpose.
N/A
Intended Use / Indications for Use
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Warantec Custom Abutments are used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. That is customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. The Warantec Custom Abutment are made of Ti-6A1-4V ELI (ASTM F136). These devices are supplied non-sterile and autoclaved by the end user and intended for single use only. Warantec Custom Abutments are compatible with IU Implant System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous or partially edentulous maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
· Steam sterilization validation according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10-6.
• Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Warantec submission, K172345, using the same materials and manufacturing processes as the subject device.
• Fatigue testing was conducted on the worst case according to ISO 14801:2016 and the FDA Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Abutment.
· Non-clinical worst-case MRI review was performed to evaluate the metallic IU System Abutment devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Warantec Co., Ltd. Younggwang Choi RA Team Manager 411~412, 474, Dunchon-dearo, Jungwon-gu Seongnam-si, Gyeonggi-do 13229 REPUBLIC OF KOREA
Re: K221972
Trade/Device Name: Warantec Custom Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 6, 2023 Received: September 6, 2023
Dear Younggwang Choi:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K221972
Device Name Warantec Custom Abutment
Indications for Use (Describe)
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantecvalidated milling center for manufacture.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the word "WARANTEC" in a sans-serif font. The color of the text is a light teal. The letters are evenly spaced and appear to be a logo or brand name.
510(k) Summary – K221972
September 28, 2023
1. Submitter
| Submitter | |
|---|---|
| Name | WARANTEC Co., Ltd. |
| Address | 411-412, 474, Dunchon-daero, Jungwon-gu, Seongnam-si, |
| Gyeonggi-do, 13229, Rep. of Korea | |
| Phone/Fax | +82-2-3675-5851/ +82-2-3675-5853 |
| Contact person | Younggwang Choi / RA |
| ygchoi@oneplant.co.kr | |
| Summary Date | September 28, 2023 |
2. Device information
| a) | Trade Name : | Warantec Custom Abutment |
|---|---|---|
| b) | Common Name : | Endosseous Dental Implant Abutment |
| c) | Classification Name : | Endosseous Dental Implant Abutment |
| d) | Product Code : | NHA |
| e) | Regulation Number : | 872.3630 |
| f) | Class of device : | Class II |
| g) | Panel : | Dental |
3. Predicate deivces"
-
Primary Predicate Device: a)
Prosthetic System / OSSTEM Implant Co., Ltd. / K110308 -
Reference Device: b)
Ti-Blank / Dentium Co., Ltd. / K161713
Elos Accurate® Customized Abutment / Elos Medtech Pinol A/S / K192457
IU Implant System / Warantec Co., Ltd. / K172345
510(k) Summary
5
4. Device description
Warantec Custom Abutments are used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. That is customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. The Warantec Custom Abutment are made of Ti-6A1-4V ELI (ASTM F136). These devices are supplied non-sterile and autoclaved by the end user and intended for single use only. Warantec Custom Abutments are compatible with IU Implant System.
5. Indication for use
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.
6
Wall
6. Substantial equivalence comparison
The Waratnec Custom Abutment is similar designs and dimensions, and has the same material, intended use, surface treatment and technological characteristics as the identified primary predicate device (K110308) and reference devices (K161713/K192457/K172345). When compared with predicate device, no new questions of substantial equivalence have been raised for the Warantec Custom Abutment.
| Device Name | Indication for use | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Warantec Custom | |||||||||
| Abutment | |||||||||
| (Subject device) | The Warantec dental abutment is intended to be used with the root-form | ||||||||
| endosseous dental implant to aid in prosthetic rehabilitation. |
All digitally designed abutments for use with Warantec Custom Abutments are
intended to be sent to a Warantec-validated milling center for manufacture. | | | | | | | | |
| Prosthetic System
(Primary Predicate
Device: K110308) | Prosthetic System is intended for use with a dental implant to provide support for
prosthetic restorations such as crowns, bridges, or overdentures. | | | | | | | | |
| Dentium CAD/CAM
Abutments
(References Predicate
Device: K161713) | Dentium abutments are intended for use on endosseous dental implants in the
edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic
rehabilitation. All digitally designed abutments for use with Dentium CAD/CAM
Abutments are intended to be sent to a Dentium-validated milling center for
manufacture. | | | | | | | | |
| Elos Accurate®
Customized
Abutment
(References Predicate
Device: K192457) | The Elos Accurate® Customized Abutments are intended for attaching to dental
implants in order to provide basis for single or multiple tooth prosthetic
restorations. The Elos Accurate® Customized Abutment will be attached to a
dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutments are compatible with the implant
systems listed in table 1:
Table 1. | | | | | | | | |
| | Elos Accurate
Customized
Abutment –
Model Type Platform
compatibility Platform
diameter
[mm] Implant Body
diameter
[mm] AB-NBR43 Nobel Replace
RP 4.3 4.3 | | | | | | | | |
7
| | AB-NBR50 | Nobel Replace
WP | 5 | 5 |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----|-----------|
| | AB-NBR60 | Nobel Replace
6.0 | 6 | 6 |
| | AB-NBA35 | Nobel CC NP | 3.5 | 3.5 &3.75 |
| | All digitally designed CAD/CAM customizations for the Elos Accurate®
Customized Abutments are only
intended to be sent and manufactured at a FDA registered Elos Medtech
approved milling facility. | | | |
| IU Implant System
(References Predicate
Device: K172345) | The IU Implant System is intended to be surgically placed in the bone of the
upper or lower jaw arches to provide support for prosthetic devices, such as
artificial teeth, and to restore the patient's chewing function. | | | |
The subject device (Warantec Custom Abutment) has substantially the equivalent in indications and design principles as the predicate and reference devices listed above.
All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and rehabilitation of the edentulous maxilla and mandible.
The only differences between the target device IFUS(Indications for Use Statements) and the reference device are specific device names, compatible implant lines and CAD/CAM manufacturing/milling descriptions and requirement for the use of validated milling centers.
None of these minor differences impact substantial equivalence. because all IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
8
WARANTEC
Device comparison
| Device Name | Subject Device | Primary Predicate | Referenced Predicate | Referenced Predicate |
|---|---|---|---|---|
| Warantec Custom Abutment | Prosthetic System | Ti-Blank | Elos Accurate® Customized | |
| Abutment | ||||
| Company | Warantec Co., Ltd. | OSSTEM Implant Co., Ltd. | Dentium Co., Ltd. | Elos Medtech Pinol A/S |
| Predicate 510k | New Device | K110308 | K161713 | K192457 |
| Classification and Product Code | Class II; 872.3630; NHA | Class II; 872.3630; NHA | Class II; 872.3630; NHA | Class II; 872.3630; NHA |
| Type of abutment | Abutments for single | Abutments for single | Abutments for single | Abutments for single |
| tooth or cemented bridge | tooth or cemented bridge | tooth or cemented bridge | tooth or cemented bridge | |
| Characteristics | Customizable to desired shape | Customizable to desired shape | Customizable to desired shape | Customizable to desired shape |
| Predicate Material | Titanium Alloy 6Al-4V | Titanium alloy | Pure Ti Grade 4 | Titanium Alloy 6Al-4V |
| (ASTM F136) | (ASTM F136) | (ASTM F67) | ELI, medical grade 5 | |
| Surface Treatment | None | None | None | None |
| Angulation (°) | 0 to 30° | 0 to 30° | 0 to 30° | 0 to 30° |
| Total Length | 14.4mm | Not defined | Not defined | Not defined |
| Post Height(mm) | 4.0~8mm | Not defined | Not defined | 4.0~13mm |
| Diameter(mm) | 3.6~6.0mm | 3.6-5.0mm | 3.6-5.0mm | 3.5~6.0mm |
| Gingival Height | 0.5~4.0mm | Not publicly available | Not publicly available | 0.5mm~5.0mm |
| Minimum Thickness | 0.4 mm | Not defined | Not defined | 0.4 mm |
| Use | Prescription | Prescription | Prescription | Prescription |
| Production | Turned and Milled | Turned and Milled | Turned and Milled | Turned and Milled |
9
warantec
The subject device is substantially equivalent to the predicate device in design, function, manufacture and intended use.
All devices are cylindrical titanium abutment with a precision implant/abutment interface for use in fabricating a patient-specific abutment.
The subject device is different from the predicate device interface, specific cylinder size, and specific abutment dameters. However, the subject device sizes are within the size range of the primary predicate.
Additionally, the Indications for Use of the subject and primary predicate device than the compatible implant bodies. This difference is mitigated by fatigue testing, and identification of recompatible implant bodies. Both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.
Any differences in technology characteristics are accompanied by information that device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.
Therefore, these minor differences do not affect the determination of substantial equivalence.
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7. Non-clinical testing data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
· Steam sterilization validation according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10-6.
• Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Warantec submission, K172345, using the same materials and manufacturing processes as the subject device.
• Fatigue testing was conducted on the worst case according to ISO 14801:2016 and the FDA Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Abutment.
· Non-clinical worst-case MRI review was performed to evaluate the metallic IU System Abutment devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
No clinical data were included in this submission.
8. Conclusion
The subject device has the similar technological characteristics to the predicate device, main material, indication for use and design.
Based on the information provided for this premarket notification of Warantec Co., Ltd. conclude that Warantec Custom Abutment are substantially equivalent to predicate devices.